Nuwellis Reports Third Quarter 2025 Results and Continued Operational Momentum

Rhea-AI Summary

Nuwellis (Nasdaq: NUWE) reported third quarter 2025 results on Nov 12, 2025, delivering $2.2 million total revenue, down 6% year‑over‑year and up 29% sequentially.

The company reported a 65.2% gross margin, operating expenses of $4.1 million (up 30% YoY) and an operating loss of $2.7 million. Nuwellis ended the quarter with $3.1 million cash, no debt, and raised $1.9 million through an ATM.

Operational milestones include first Aquadex therapies delivered in hospital‑based outpatient settings under a new CMS code, U.S. launch of a 24‑hour circuit and dual‑lumen extended‑length catheter, accelerated pediatric development via an NIH‑funded collaboration and a newly issued U.S. patent, plus a manufacturing transition and international wind‑down to focus on U.S. growth.

Positive

• Revenue +29% sequentially in Q3 2025
• First Aquadex therapies delivered in hospital‑based outpatient setting under new CMS code
• U.S. launch of 24‑hour circuit and dual‑lumen extended‑length catheter
• NIH‑funded pediatric collaboration and newly issued U.S. patent
• Raised $1.9 million via ATM and ended quarter debt‑free with $3.1 million cash

Negative

• Total revenue down 6% year‑over‑year to $2.2 million
• Gross margin declined from 70.0% to 65.2% (480 basis points)
• Operating expenses +30% year‑over‑year, driving operating loss to $2.7 million (vs $1.5M)

Insights

Healthcare MedTech Financial Analyst

Mixed quarter: U.S. traction and product launches offset by narrower margins and small cash runway.

Nuwellis reported $2.2 million revenue for the quarter, down year‑over‑year but up sequentially, driven by higher consumable use and more U.S. console placements. The business model relies on recurring consumable sales tied to installed consoles and new outpatient use cases enabled by a CMS code and the 24‑hour circuit launch.

Profitability contracted: gross margin fell to 65.2% and operating loss widened to $2.7 million, driven by manufacturing utilization and higher sales force and engineering costs. The company ended the quarter with $3.1 million cash, remains debt‑free, and raised $1.9 million via ATM in the period. Those facts indicate a limited near‑term liquidity buffer and higher burn after investments.

Key dependencies include successful U.S. console adoption, consistent consumable repeat orders, and a smooth manufacturing transition to KDI. Monitor quarterly consumable revenue trend, U.S. console placement cadence, progress on the NIH pediatric collaboration, and cash runway over the next 2–4 quarters. These items will determine whether sequential momentum converts into sustainable growth.

Company delivers steady performance and achieves key milestones across critical care, pediatrics, and hospital-based outpatient therapy

MINNEAPOLIS, MN, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, addressing the critical interplay between the heart and kidneys, today reported financial results for the third quarter ended September 30, 2025 and provided a business update on recent milestones advancing the company’s cardiorenal growth strategy.

Third Quarter 2025 Highlights

• Total revenue of $2.2 million, down 6% year-over-year and up 29% sequentially, reflecting increased consumable utilization and stronger U.S. console sales on a sequential quarter basis. On a pro-forma basis, revenue grew approximately 7% year-over-year, after excluding one-time SeaStar Medical revenue of $0.2 million in the year quarter and a $0.1 million year-over-year decrease in international revenue associated with the commencement of international wind-down activities in the third quarter.
• All customer categories achieved year-over-year growth in circuit sales, highlighting broader adoption across critical care, heart failure, and pediatrics.
• First Aquadex^® therapies delivered in a hospital-based outpatient setting, under new CMS code. A major step forward in expanding access to safe, efficient ultrafiltration therapy.
• U.S. launch of new 24-hour circuit and dual-lumen extended-length catheter, enhancing provider flexibility across inpatient and hospital-based outpatient programs.
• Pediatric product development accelerated through an NIH-funded collaboration to advance the Vivian™ pediatric CRRT system and a newly issued U.S. patent supporting broader platform innovation.
• Initiated manufacturing transition to KDI Precision Manufacturing and exit of international operations to focus on U.S. market growth.
• Raised $1.9 million through ATM facility in the quarter.
  

Management Commentary

“Our third quarter results reflect disciplined execution and meaningful progress toward building a more focused, U.S.-driven business,” said John Erb, Chairman and Chief Executive Officer of Nuwellis. “We continue to strengthen our leadership in precision fluid management across critical care, pediatrics, and hospital-based outpatient therapy. With the launch of our new 24-hour circuit and successful early hospital-based outpatient treatments, we are expanding how and where Aquadex therapy can be delivered to improve patient outcomes.”

Third Quarter 2025 Financial Results

Total revenue for the third quarter of 2025 was $2.2 million, compared to $2.4 million in the prior year quarter. On a pro-forma basis, revenue grew approximately 7% year-over-year, after excluding one-time SeaStar Medical revenue of $0.2 million in the prior year period and a $0.1 million decrease in international revenue due to the commencement of international wind-down activities in the third quarter.

Sequentially, revenue increased 29% from the second quarter, driven by higher consumable utilization and increased U.S. console placements.

Gross margin was 65.2%, compared to 70.0% in the prior year quarter, driven by unfavorable manufacturing utilization in the first half of fiscal year 2025, which was recognized in Costs of Sales in the third quarter.

Operating expenses totaled $4.1 million, up 30% year-over-year, reflecting increased investment in rebuilding the U.S. sales force to historical headcount levels and additional investments in sustaining engineering and quality systems.

Operating loss was $2.7 million, compared to $1.5 million last year.

The company ended the quarter with $3.1 million in cash and cash equivalents and remains debt-free.

Conference Call and Webcast Information

Nuwellis management will host a conference call today, November 12, 2025, to discuss financial results and provide a business update.

To access the live webcast, please visit the Investors page at https://ir.nuwellis.com. Alternatively, participants can join the live conference call by dialing 1-800-274-8461 (U.S.) or 1-203-518-9814 (international) and using the conference ID: NUWEQ3. A replay will be available following the call on the Investors page on the company’s website.

For more information, visit www.nuwellis.com.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company advancing precision fluid management therapies to improve recovery and outcomes for cardiorenal syndrome patients. Through our Aquadex^® SmartFlow system, we make fluid balance measurable, controllable, and consistent—supporting clinicians with technology designed for accuracy and confidence in care. Headquartered in Minneapolis, MN, with a wholly owned subsidiary in Ireland, Nuwellis is redefining the standard for fluid management. For more information visit www.nuwellis.com or visit us on LinkedIn or X, formerly known as Twitter.

About the Aquadex SmartFlow^® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

About Vivian Vivian is a purpose-built pediatric CRRT system designed for neonates and children. The platform targets an extracorporeal blood volume of 29–67 mL and features integrated hematocrit and SvO₂ sensors for real-time monitoring. Vivian brings three therapies—Ultrafiltration (UF), Continuous Veno-Venous Hemofiltration (CVVH), and Continuous Veno-Venous Hemodialysis (CVVHD)—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. A guided, clinician-informed interface with on-screen prompts streamlines setup and reduces training burden, while a 6-port circuit provides flexible vascular-access options. Intended for patients 2.5–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity for the most fragile patients.

Disclaimer: Vivian is an investigational device, under development, and not available for sale. Features and specifications are subject to change.

Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2025 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.

For further information, please contact:

Investor Relations:
ir@nuwellis.com

Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com

NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
	September 30, 2025				December 31, 2024
ASSETS	(Unaudited)
Current assets
Cash and cash equivalents	$	3,094			$	5,095
Accounts receivable		1,141				1,727
Inventories, net		2,189				1,718
Other current assets		776				315
Total current assets		7,200				8,855
Property, plant and equipment, net		414				478
Operating lease right-of-use asset		349				510
Other assets		21				21
TOTAL ASSETS	$	7,984			$	9,864
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued liabilities	$	2,668			$	1,640
Accrued compensation		523				640
Current portion of operating lease liability		255				238
Other current liabilities		76				41
Total current liabilities		3,522				2,559
Warrant liabilities		420				468
Operating lease liability		128				307
Total liabilities		4,070				3,334
Commitments and contingencies
Mezzanine Equity
Series J Convertible Preferred Stock as of September 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 127 and 102, respectively		6				2
Stockholders’ equity
Series A junior participating preferred stock as of September 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 30,000 shares, none outstanding		—				—
Series F convertible preferred stock as of September 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 27 and 127 shares, respectively.		—				—
Series F-1 convertible preferred stock as of September 30, 2025 and December 31,2024, par value $0.0001 per share; authorized 100 shares, issued and outstanding 34 and 0 shares, respectively		—				—
Preferred stock as of September 30, 2025 and December 31, 2024, par value		—				—
$0.0001 per share; authorized 39,352,000 shares, none outstanding
Common stock as of September 30, 2025 and December 31, 2024, par value		—				—
$0.0001 per share; authorized 100,000,000 shares, issued and outstanding
1,364,970 and 104,142, respectively
Additional paid-in capital		317,852				305,366
Accumulated other comprehensive income:
Foreign currency translation adjustment		(54	)			(47	)
Accumulated deficit		(313,890	)			(298,791	)
Total stockholders’ equity		3,908				6,528
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY	$	7,984			$	9,864

	NUWELLIS, INC. AND SUBSIDIARY
	Condensed Consolidated Statements of Operations and Comprehensive Loss
	(Unaudited)
	(in thousands, except per share amounts and weighted average shares outstanding)
			Three months ended						Nine months ended
			September 30						September 30
				2025			2024			2025			2024
	Net sales		$	2,217		$	2,367		$	5,846		$	6,418
	Cost of goods sold			772			711			2,376			2,097
	Gross profit			1,445			1,656			3,470			4,321
	Operating expenses:
	Selling, general and administrative			3,539			2,702			10,305			10,544
	Research and development			603			486			1,828			2,378
	Total operating expenses			4,142			3,188			12,133			12,922
	Loss from operations			(2,697	)		(1,532	)		(8,663	)		(8,601	)
	Other income (expense), net			4			8			21			(87	)
	Financing expense			—			—			(10,553	)		(5,607	)
	Change in fair value of warrant liabilities			3,161			3,882			4,101			4,602
	Income (loss) before income taxes			468			2,358			(15,094	)		(9,693	)
	Income tax expense			—			—			(5	)		(4	)
	Net income (loss)		$	468		$	2,358		$	(15,099	)	$	(9,697	)
	Deemed dividend attributable to Series J Convertible Preferred Stock			1			—			3			541
	Net income (loss) attributable to common shareholders		$	469		$	2,358		$	(15,096	)	$	(9,156	)
	Basic and diluted income (loss) per share		$	0.56		$	73.23		$	(39.51	)	$	(142.11	)
	Weighted average shares outstanding – basic and diluted			836,386			204,710			382,123			68,237
	Other comprehensive loss:
	Net income (loss)		$	468		$	2,358		$	(15,099	)	$	(9,697	)
	Foreign currency translation adjustments		$	(1	)	$	(4	)	$	(7	)	$	(15	)
	Total comprehensive income (loss)		$	467		$	2,354		$	(15,106	)	$	(9,712	)

NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
	Nine months ended
	September 30
		2025				2024
Operating Activities:
Net loss	$	(15,099	)		$	(9,697	)
Adjustments to reconcile net loss to cash flows used in operating activities:
Depreciation and amortization		166				227
Stock-based compensation expense		103				374
Change in fair value of warrant liabilities		(4,101	)			(4,602	)
Financing expense		10,553				5,607
Amortization of operating lease right-of-use asset		161				150
Changes in operating assets and liabilities:
Accounts receivable		586				658
Inventory, net		(471	)			120
Other current assets		(461	)			(275	)
Other assets and liabilities		35				(3	)
Lease liability		(162	)			(160	)
Accounts payable and accrued expenses		910				(486	)
Net cash used in operating activities		(7,780	)			(8,087	)
Investing Activities:
Purchases of property and equipment		(102	)			(37	)
Net cash used in investing activities		(102	)			(37	)
Financing Activities:
Issuance of common stock and warrants from offering, net		3,999				2,403
Issuance of common stock from ATM, net		1,889				—
Proceeds from the exercise of Series J Convertible Preferred Warrants		—				501
Proceeds from the exercise of April 2024 Warrants		—				1,182
Issuance of July and August 2024 Common Stock and Warrants		—				2,160
Net cash provided by financing activities		5,888				6,246
Effect of exchange rate changes on cash		(7	)			(15	)
Net decrease in cash and cash equivalents		(2,001	)			(1,893	)
Cash and cash equivalents - beginning of period		5,095				3,800
Cash and cash equivalents - end of period	$	3,094			$	1,907
Supplemental cash flow information
Reclassification of April 2024 warrants to equity	$	—			$	4,217
Issuance of Series J Preferred Stock for exercise of Warrants	$	—			$	1,857
Series A warrants conversion to equity	$	8,439			$	—
Series B warrant exercises	$	2,055			$	—
Issuance of Common Stock for conversion of Series J Preferred Stock	$	—			$	1,535
Issuance of Common Stock for conversion of Series F-1 Preferred Stock	$	1,100			$	—
Deemed dividend on Series J Preferred Stock	$	3			$	(541	)
Common stock offering costs included in prepaids	$	—			$	306

FAQ

What were Nuwellis (NUWE) revenue and profit metrics for Q3 2025?

Nuwellis reported $2.2 million revenue in Q3 2025, gross margin of 65.2% and an operating loss of $2.7 million.

Why did NUWE revenue change year‑over‑year in Q3 2025?

Revenue was down 6% YoY, with management noting a $0.2M one‑time SeaStar Medical amount in the prior year and a $0.1M international decrease from wind‑down activity.

How is Nuwellis expanding Aquadex access in 2025 for NUWE shareholders?

Nuwellis delivered first Aquadex therapies in hospital‑based outpatient settings under a new CMS code and launched a 24‑hour circuit plus a dual‑lumen extended‑length catheter to broaden use cases.

What capital did Nuwellis raise in Q3 2025 and what was the cash position for NUWE?

The company raised $1.9 million through an ATM in Q3 and ended the quarter with $3.1 million in cash and no debt.

Did Nuwellis report product or R&D milestones in Q3 2025 for NUWE?

Yes — an NIH‑funded collaboration to advance the Vivian pediatric CRRT system and a newly issued U.S. patent supporting platform innovation were announced.

What operational changes did Nuwellis report that may affect NUWE's focus?

Nuwellis initiated a manufacturing transition to KDI Precision Manufacturing and commenced an international operations wind‑down to focus on U.S. market growth.